Kornimate/medical-research-clean huggingface dataset:
a rct evaluating the clinical benefit of a silver dressing in the treatment of venous leg ulcers

Conditions: Wound Heal

Summary: approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. all subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.


Eligibility criteria:
inclusion criteria: * has signed informed consent * is above 18 years of age or above and has full legal capacity * has venous leg ulcer (c6 of the ceap classification) with a duration longer than 4 weeks but no longer than 5 years * has acceptance of compression bandages * has a wound at risk of infection based on war (wounds at risk of infection) score with score of ≥3 points or has at least three of the following clinical signs of bacterial contamination based on the therapeutic index for local infections (tili) score: * erythema to surrounding skin * heat * oedema, induration or swelling * spontaneous pain or pressure pain * stalled wound healing * increase and/or change of color or smell of exudate * has wound area of min 1x1 cm and max 10x10 cm * has wound with depth of max 2 cm * has wound with medium to high level of exudate (but should not require more than 1 dressing change/day) * has ankle-brachial pressure (abi) ≥0.8 and, for patients with diabetes mellitus, additional biphasic doppler signal up to the ankle * ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period * for patients with diabetes, has hba1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion * should be able to follow the study protocol with the prescribed cleansing product (nacl) and dressing exclusion criteria: * is pregnant or breastfeeding * has wounds with exposed tendons, bones, fistulas. or wounds with cavity, undermined or tunnelling * has infection requiring antibiotics (also for other reasons than wound infection) or has received antibiotics within the last 1 week before inclusion * has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed * has a systemic hematological disease * has renal insufficiency requiring dialysis * has advanced heart failure nyha iii/iv * has a psychiatric illness that inhibits compliance with the study protocol * has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (scid) * has allergy towards silver or other dressing ingredients (including compression therapy) * has wound with \> 50% necrotic tissue * treatment of wound with an anti-microbial wound dressing within the last 2 weeks
a study of alks 8700, a monomethyl fumarate (mmf) molecule, in healthy adults

Conditions: Multiple Sclerosis

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics of alks 8700, a monomethyl fumerate (mmf) molecule.

this study record was previously posted/updated by alkermes, inc. as of 29 oct 2019, the sponsorship of the trial was transferred to biogen along with responsibility for subsequent updates to the record.

Eligibility criteria:
inclusion criteria: * has a body-mass index (bmi) \>/=18.0 and \</=32.0 kg/m2 * agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration * additional criteria may apply exclusion criteria: * is currently pregnant or breastfeeding * has a lifetime history of menopausal hot flashes * has a clinically significant medical condition * has had a clinically significant illness in the 30 days prior to first study drug administration * has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration * has had any vaccinations in the 4 weeks prior to inpatient admission * has a lifetime history of diabetes * additional criteria may apply

Keywords: alkermes alks 8700
safety and effectiveness study of a non-crosslinked ha alkylamide hyadd(tm) 4 hydrogel for osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee. exclusion criteria: * no disorders which could interfere with study required assessments.

Keywords: hyaluronic acid osteoarthritis knee hyaluronan viscoelastic hydrogel
efficacy of inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy

Conditions: Patellar Tendinitis; Jumper's Knee

Summary: the purpose of this project is to investigate the efficacy of inertial flywheel resistance program vs heavy slow resistance in patients with chronic patellar tendinopathy. the investigators hypothesize that inertial flywheel resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.

randomized controlled intervention study

Eligibility criteria:
inclusion criteria: * clinical diagnosis of patellar tendinopathy * symptoms \> 3 months * pain localized to the inferior pole of the patella * victorian institute of sport assessment (visa) score less than 80 points * palpation tenderness of the patellar tendon * abnormal tendon (hypoechoic) confirmed by ultrasonography. exclusion criteria: * previous knee surgery * confounding diagnosis to the knee joint * previous corticosteroids injections * arthritis or diabetes
inspiratory muscle training in obese breast cancer survivors

Conditions: Cancer Survivors; Obesity; Breast Cancer

Summary: the investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-iii obese breast cancer survivors.

randomized controlled trial (rct) where obese participants (n=133) are randomized to 2 arms: \[i\] imt 4 wks + exercise 12 wks, \[ii\] sham 4 wks + exercise 12 wks).

Eligibility criteria:
inclusion criteria: * completed active treatment for a stage 0-iii breast cancer diagnosis within 6 months to 5 years of enrollment. * obese as defined by a body mass index (bmi) of 30 to 50 kg/m2 * patients who are on adjuvant endocrine therapy will be allowed to participate. * sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question rand-36 physical function subscale to ensure some exercise intolerance exclusion criteria: * functional limitations that make independent exercise unsafe * metastatic breast cancer * ongoing or active infection with recent antibiotics or steroids * bilateral axillary lymph node dissection (alnd) of \>5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated bp measures on both arms. bilateral sentinel lymph node biopsy (slnb) will be allowed. * heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia) * psychiatric illness/social situations that would limit compliance with study requirements * orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise * unwilling or unable to follow protocol requirements * pregnant or nursing * any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study * presence of provokable ecg changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test * non-english speaking
radiological measurement of femoral stem version using lateral decubitus method: a prospective study

Conditions: Arthroplasty; Total Hip Replacement

Summary: the purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (thr) as well as the position of the acetabular component. however, there is no radiological method of measuring stem anteversion described in the literature. investigators propose a radiological method to measure stem version and have assessed its reliability and validity. in 40 patients who underwent thr, a hip radiograph and ct scan were taken to measure stem anteversion.

Eligibility criteria:
inclusion criteria: * investigators recruited 40 consecutive patients who underwent thr between october 2015 and december 2015 exclusion criteria: * patients who could not extend the hip because of a residual flexion contracture. * who had a flexion contracture of the knee or who could not flex the hip to 90° even after thr were excluded because participants could not adopt the posture required for the particular radiographs and ct scans.

Keywords: total hip stem version replacement hip
survey of prevalence of loss of appetite in subject with health disorders

Conditions: Appetite

Summary: the study is an epidemiological survey to find out the incidence of loss of appetite in indian patients suffering from various health disorders. this survey will be conducted to obtain information on appetite from a total of 17500 subjects this study does not intend to study the effect of any drugs. the primary source of information will be the subjects themselves. the study will be conducted at 275 - 350 centres spread across india.this is a single visit study.the physician will conduct routine clinical, physical and general examination.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:malaria fever, typhoid or enteric fever * hepatitis * acute infections including respiratory, urinary tract infections etc treated with antibiotic * tuberculosis * patient discharged from hospital after general surgical procedures like acute appendectomy, etc. * any other condition exclusion criteria: * patients unwilling to provide informed consent \& comply with the study procedure * patient using drugs which affect appetite like cyproheptadine etc.

Keywords: appetite
intervention strategy in chronic obstructive pulmonary disease with anxiety and depression

Conditions: COPD; Anxiety; Depression

Summary: anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (copd). intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. but there's not standard algorithm in china so far. the study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in copd.


Eligibility criteria:
inclusion criteria: * stable copd patients with mild or moderate anxiety and depression exclusion criteria: * patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months * patients with tumor history during past 5 years * patients with copd exacerbations during past 4 weeks * participants in clinical trials * patients in pregnancy or breastfeeding * patients unable to complete questionaire independently * patients older than 80 years old * patients receiving long-term domiciliary oxygen therapy
the staple international post-market registry

Conditions: Aortic Aneurysm, Abdominal; Aorto Iliac Aneurysm

Summary: the aptus endosystems staple international post-market registry is intended to expand the clinical knowledge base by including 'real world' subjects.

the aptus endosystems staple international post-market registry is intended to expand the clinical knowledge base by including 'real world' subjects. all subjects diagnosed with a qualifying aaa suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.

Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years old 2. patient has given written informed consent 3. patient has a life expectancy \> 1 year 4. patient is willing to comply with follow-up evaluations 5. patient's aaa meets at least one of the following criteria: * ≥ 4.5cm in diameter * increased in size by 0.5cm in last 6 months * maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment * saccular aneurysm larger than 3cm in maximal diameter 6. patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm 7. patient has a proximal aortic neck length of at least 12mm 8. patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16fr (5.3mm) or 18fr (6.0mm) delivery system. 9. patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm exclusion criteria: 1. patient is participating in a concurrent clinical study which may confound staple-international registry results 2. patient has a symptomatic aaa 3. patient's aaa has a proximal aortic neck angle that is \> 60 degrees between the infrarenal neck and the long axis of the aneurysm 4. patient has irregularly-shaped plaque that would inhibit sealing stent apposition 5. patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site 6. patient has an active, or known history of, bleeding diathesis or hypercoagulable condition 7. patient has a contraindication to any materials to which he or she will be exposed during the evar procedure (i.e., fortevo endograft or heli-fx endoanchor system materials, contrast agents) 8. patient has a genetic connective tissue disorder (e.g., marfan's or ehlers-danloe syndromes)

Keywords: aptus endosystem endostaple endograft stent graft abdominal aortic aneurysm heli-fx endoanchor
assessing the impact of different compression of the hand versus free hand on the implementation of the precision grip

Conditions: Burned Hands

Summary: the purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (box and block / purdue peg board / jamar's test)

patients with burned hands will realise prehension test to explore dexterity of hand when they wear compressive's treatments and with free hands. each patient will realise each test with all conditions (free hands/ made to measure gloves/ compressive bandaging). running order of test and condition is randomly defined. each patient realized this tests under the care and devices used at usual care. realisation of this tests are not influenced by the study. patient realised this tests during reeducation.

Eligibility criteria:
inclusion criteria : * patient admitted from leon bérard hospital * burn hand with 2nd or 3nd degree depp * dominant hand if bilateral's burning * patients requiring compression of the hand * patient receiving final compression gloves since seven days ± two days weekend * patient affiliated to a social security exclusion criteria : * no burning of the hand * contraindication for the use of compression * incompatible articular balance with achievement tests * patients already included in a second study * minor patient or pregnant woman * presence of cognitive disorder, preventing the achievement of tests * guardianship or individual under the protection of a conservator * patients not receiving social security

Keywords: hands
remote ischemic preconditioning for subcortical vascular dementia

Conditions: Subcortical Vascular Dementia

Summary: the purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.

in this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. the participants had a diagnosis of subcortical vascular dementia at the neurology department of tianjin medical university general hospital. inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. all participants received standard medical management.participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. the remote ischemic precondition procedure was performed once daily over 180 consecutive days. cognitive impairment assessment scale ( hopkins verbal learning test,hvlt;symbol digital modalities tes,sdmt;judgement line orientation, jlo;trail making test a and b,tmt-a/b;chinese word fluency test;activity of daily living scale,adl;neuropsychiatric inventory,npi), serological inflammatory markers:hypersensitive c-reactive protein（hs-crp）、plasma tumor necrosis factor-α(tnf-α)、interleukin-1β(il-1β)、interleukin-6 (il-6)、α1-antichymotrypsin),and mri diffusion tensor imaging, dti were compared with the untreated control group.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of vascular dementia 2. in three months without cerebral infarction 3. mmse 15 to 26 points;cdr 1-2 points;moca \< 26 points 4. mri showed subcortical ischemic cerebrovascular disease. exclusion criteria: 1. ad 、 ftd, dlb and other causes of dementia. 2. cortical/subcortical infarction 3. cortex watershed infarction 4. cerebral hemorrhage 5. hydrocephalus 6. other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc. 7. cannot complete aphasia neuropsychological assessment. 8. genetic or inflammatory small vascular disease. 9. serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease. 10. alcohol poisoning; 11. cancer 12. hypothyroidism 13. schizophrenia;hamilton depression rating scale \> 17 points. 14. can not complete mri.
raltegravir intensification in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether treatment with raltegravir further decreases hiv viral replication in haart-suppressed, hiv-infected patients, potentially improving immune response to antiretroviral therapy.


Eligibility criteria:
inclusion criteria: * stable antiretroviral therapy for at least 12 months * screening cd4+ t cell count \< 350 cells/mm3 * all available cd4+ t cell counts in the last year and at screening \< 350 cells/mm3 * screening plasma hiv rna levels below level of detection (\ 75 but \< 1000 copies/ml will be allowed if they were preceded and followed by undetectable viral load determinations). * \>90% adherence to therapy within the preceding 30 days, as determined by self-report * both male and female adult (at least 18 years old) subjects are eligible. females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. exclusion criteria: * patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason * serious illness requiring hospitalization or parental antibiotics within preceding 3 months * \*\*any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period * concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks * concurrent treatment with phenobarbital, phenytoin, or rifampin. * screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<70,000 cells/mm3, hemoglobin \< 8 mg/dl, estimated creatinine clearance \<40 ml/minute * pregnant or breastfeeding women

Keywords: hiv treatment intensification low level viremia suboptimal cd4+ t cell response treatment experienced
amygdala and dlpfc mri-tis for depression in adolescents

Conditions: Major Depressive Disorder

Summary: the study utilizes a non-invasive deep brain stimulation (temporal interference, ti) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of mri-compatible ti technology in regulating the amygdala in adolescent depressive disorders.


Eligibility criteria:
inclusion criteria: * participants must be aged between 14 and 18, with no gender restrictions; * a diagnosis of depression made by the study physician based on the diagnostic and statistical manual of mental disorders (dsm-5); * hamd-17 score of 17 or higher; * participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment; * eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form. exclusion criteria: * eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy; * participants must not have a history of seizures or prior episodes of epilepsy; * the presence of metallic foreign objects within the cranial structure or metallic cardiac implants; * participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention; * participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy); the researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior; * pregnant or breastfeeding; * participants who are concurrently engaged in other clinical interventional trials; * participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied

Keywords: adolescents deep brain stimulation major depressive disorder temporal interference amygdala
ventilation using a bag valve mask with integrated internal handle

Conditions: Apnea

Summary: investigators compared tidal volumes for single rescuer ventilation using a modified bag valve mask with an integrated internal handle versus a conventional bag valve mask in a manikin model.

this was a prospective, randomized, crossover study to assess the tidal volume delivered using a standard and modified bag valve mask (bvm) device in a manikin airway model. data was collected from july 2015 through october 2015 at the san antonio military medical center. emergency medicine providers (physicians, physician assistants, residents, nurses, medics) were randomized to device order. prior to participation each participant filled out a survey indicating their job status, gender, years of medical experience, and experience level with bvm ventilation. hand grip strength and size (length, width, span) were measured. each participant was then asked to provide bvm ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. tidal volume of each delivered breath was recorded in milliliters. after a 3 minute rest period, testing was repeated with the second device. after ventilation with each device, participants completed an anonymous questionnaire that used a likert scale to assess perceived qualities of the modified device including ease of use, ability to provide a superior mask seal, willingness to use in an emergency situation, and overall preference between the two devices. each participant served as his/her own control.

Eligibility criteria:
inclusion criteria: * emergency department healthy volunteers (physician assistants, residents, paramedics, nurses, medics, respiratory therapists. exclusion criteria: * not trained in basic life support